Get personal

At its simplest, personalised medicine means using genetics to identify the biological profiles of patients, devising diagnostic tests for patients and prescribing the medicines that would best suit them. It is an exciting and potentially huge new area that has opened up since the mapping of the human genome. The benefits for patients, health professionals and state-funded health systems are clear. Less clear is what personalised medicine will mean for pharma.

Patient benefitsFew health professionals, or their patients, would disagree with the need to prescribe medicines more appropriately. In many cases, the selection of drugs takes a hit or miss approach. Doctors prescribe medicines, see if they work and, if not, try others in turn until the right ones are found. From both the doctor and patient perspective, the disadvantages of this approach are significant:

Improvements to the patient's health are delayed while trying to find an appropriate therapy

Patients may lose confidence in their drugs, resulting in issues of non-concordance

Patients may even lose confidence in their healthcare professionals.

In the simplest terms, personalised medicine often provides a better bet for patients and healthcare professionals.

Payer AdvantageFrom a payer perspective, the advent of personalised medicine also offers advantages. In 2007 Harvard Business Review published findings from multiple studies showing that most drugs currently prescribed in the US are effective in fewer than 60 per cent of cases. This appears particularly true for cardiovascular drugs, antidepressants and asthma beta2-agonists.

The clear cost-saving implications of reducing such waste are obvious. Given the current drive to cut state-funded healthcare budgets, it is hardly surprising that there is a growing interest in personalised medicine from governments throughout Europe.

Genetic testingMuch genetics work to date has been concerned with rare, inherited disorders caused by a defect in a single gene or chromosome that results in a specific medical condition or syndrome such as cystic fibrosis, haemophilia and muscular dystrophy. However, genetic markers are now being listed for common chronic disorders including diabetes, heart disease, Crohn's disease, and several common cancers. Personalised medicine is moving into the mainstream.

In its 2005 public health programme, the European Commission called for the identification of public health issues linked to current national practices in applying genetic testing and on that basis contribute to developing best practice in applying genetic testing.

Positive conclusions are beginning to emerge:

Gene variants can affect the amount of warfarin needed to prevent strokes while avoiding serious bleeding. Genetic testing can help establish the correct dose for an individual patient.

Patients with prostate cancer, who lack the genes that cause an aggressive form of the disease, can avoid radical surgery, radiation and chemotherapy.

A genetic trade-off between type 2 diabetes and prostate cancer has been identified, with the discovery of genes that can raise the risk of one condition while protecting against the other. This should help scientists to avoid designing drugs aimed at one disorder that inadvertently trigger another.

Genetic testing has shown that a well-known drug for breast cancer is being prescribed for HER2-negative patients, who do not benefit from it.

HIV testing can determine the current genetic make-up of a patient's virus, so that drug therapy can be tailored accordingly.

Pharma's ResponsePharma seems to be divided on the issue. On one side are the companies that appear to be waiting for the return of the halcyon days of blockbuster drugs and share-inflating pipelines. While they wait, it is easy to see why they may not wish to acknowledge publicly that a good percentage of the drugs they sell to governments across the region don't actually have the intended effect.

On the other side are those companies actively engaged in discussions with governments, health technology assessors and other national and regional bodies around risk-sharing schemes, bio-markers in clinical trials and routine genetic profiling as the potential future for healthcare provision.

We are still at the very early stages of personalised medicine but the implications for pharma are enormous. It could potentially render obsolete the current - broadly similar - European systems of medicine acquisition and with this, the development, sales, pricing, reimbursement, marketing and communication functions as we know them.

Those in the vanguard may wish to take a leaf out of the book of the biotech industry and attempt to shape the future, rather than risk being shaped by it. There are many initiatives in which they can become involved such as:

Working with governments and EU institutions to make the necessary changes to current guidelines for pricing, reimbursement and cost effectiveness metrics

Promoting the value of personalised medicine among doctors, patients and patient organisations

Clinical trialsTaken to its logical conclusion, personalised medicine would effectively mean a pharma market dominated by what we currently term orphan drugs. The use of bio-markers in clinical trials would become standard and declared, patient recruitment would be more difficult given much smaller cohorts - probably needing to be achieved across national borders.

Approved indications would become significantly more specific. First- and second-line denominations for treatments may well fall out of use.

The overall cost of medicine acquisition would fall significantly, but those companies involved in genetic profiling and bio-markers would stand to gain.

European marketsIn the short term governments throughout Europe may stick with tried and tested cost-per-QALY models when assessing cost effectiveness of treatments. They will come under pressure to alter the current thresholds, to reflect improved therapeutic efficacy, but this will not happen overnight. However, advances in genetic medicine are gathering pace. This, together with an ever-stronger imperative to reduce European health spends, will provide incentives to develop the concept of personalised medicine.

The essence of health politics is to understand when change is inevitable and look for the advantage in it rather than resist it. Some companies will embrace the move towards a personalised approach to medicine and others will wait until they have no choice but to play catch-up.

The AuthorChris Mockler is senior policy consultant to the public affairs health teamClaire Ashbridge-Thomlinson is director of healthcare strategy at Fleishman-Hillard